Hip fractures are a major health and economic problem for the elderly and our society as a whole. Greater trochanter protrudes outwardly from the proximal femur just below the joint and the adjoining thin neck of the femur. This region is relatively poorly protected by muscle and other body tissue in comparison with the regions of the hip surrounding it. In fact, the greater trochanter is readily accessible to the touch, its position being generally indicated by an elevation in the hip area due to the thinness of the tissues that cover it. Most hip fractures occur as a result of a fall from a standing (or other normal for daily activities) position. Measurements of the falling force needed to hip fracture the elderly have shown the fracture threshold to be 2,110 Newtons (see J. C. Lots and W. C. Hayes, The Journal of Bone and Joint Surgery, vol. 72-A, No. 5, June 1990, pp 689-700). Many experts predict a future epidemic of hip fractures because population of our planet is aging.
For example, according to the American Academy of Orthopaedic Surgeons, in the USA there were more than 238,000 hospitalizations for hip fractures in 1990 and more than 323,000 in 1996. The number of hip fractures could reach 512,000 by 2040 and 650,000 by 2050 (could reach more than 6,000,000 in the world by 2050). Nearly 33% of women and more than 17% of men will experience a hip fracture if they live to age 90. Furthermore, disorders such as Parkinson's Disease, Alzheimer's Disease, and stroke are associated with high annual incidence of hip fracture. Among patients who are functionally independent prior to a hip fracture, 15% to 25% remain in long-term care settings for more than a year afterward. Another 25% to 35% are dependent on others for their mobility. More than half of those that survive hip fracture never recover normal function. The death rate for hip fracture patients is higher than for other people of the same age who do not sustain the injury. As many as 20% of all people who suffer a hip fracture die within a year, usually because of complications like pneumonia or blood clots in the lung that are related to either the fracture itself, surgery to heal the break, or being confined to bed. According to the American Academy of Orthopedic Surgeons, in 1998 the cost to the U.S. health care system for acute and convalescent care for patients with hip fractures was more than $12.6 billion. That's an average of $37,000 per patient.
The prior art of hip protectors has two classes—hip protectors for using over clothing and hip protectors for using under clothing.
Hip protectors for use over clothing typically have soft or hard protective devices with permanent cubic capacity. These protectors do not combine protection, comfort and ease of use and look very unaesthetic over clothing. In the development of these protectors it was most logical to look towards the airbag, also known as the “Safety Air Cushion” (SAC). This practical device was invented and designed to protect drivers and passengers in automobile accidents. Examples of airbags and airbag inflation devices are found in U.S. Pat. No. 3,430,979, which uses pressurized gas for inflation; U.S. Pat. Nos. 4,178,016 and 4,243,248, which both use pyrotechnic devices for inflation. The solution is to provide each elderly citizen with an inflatable bag. Such a bag would be equipped with a motion detector which would sense that a fall is in progress. Upon detecting a fall, the sensor would activate a pressure source to rapidly expand the bag and thereby cushion the individual from the impact of the fall. Examples of this approach are U.S. Pat. Nos. 4,089,065; 5,500,952 & 5,867,842, which use sensor, power source, control unit, compressed gas cartridge(s) with releaser(s) and air bag(s). Such protector approach is much too complicated, needs very reliable electronic and electromechanical units, changes of compressed gas cartridge(s) after fall, and can be much too expensive to many elderly individuals.
The prior art for hip protectors for using under clothing does not achieve combined protection, comfort and ease of use too. Girdle-like undergarments of the prior art, whether using essentially pads or inflatable bags, are difficult to put on and take off, and can create other significant problems for elderly people. For example, some must be removed e. g. when bathing or going to the toilet, but a lot of hip fractures, around 20%, comes from falling on the often hard and slippery floors during bathing and going to the toilet. Examples of such devices are U.S. Pat. Nos. 4,737,994; 4,977,623 & 5,297,293. If such garments are not completely moisture resistant, they will soon become dirty and probably soiled with urine and feces. The result is unsanitary, unpleasant, unsightly and uncomfortable for both patients and attendants. Additionally, such garments, which by their very nature must fit snugly, can compromise blood circulation and could contribute to the development of decubitus ulcers, a dangerous problem with significant morbidity and even mortality in elderly, immobile and bedridden patients.
U.S. Pat. No 5,584,072, which discloses a hip protector using a belt with a hard buckle lock, a pair of holsters with hard shells and leg straps. This device can not be easily put on, adjusted to fit comfortably and removed by a person who is elderly, infirm or whose fingers, hands and grip have been weakened by arthritis and/or other neuromuscular conditions. Additionally, this hip protector is not very comfortable to a wearer because it has hard shells/shields (the same may be said of the devices of U.S. Pat. Nos. 4,641,641; 4,926,883; 5,062,433; 5,497,511; 5,636,377; 5,722,093 & 6,334,443). The results of using hard shells include different problems, for example, the discomfort during sleeping, sitting or other daily activities, and problems for washing/drying, etc. If wearer can take out hard shells from pockets before, for example, sleeping, can arise other problems: during sleeping wearer can fall from bed or after sleeping old wearer can forget put in pockets these shells—in both cases the wearer does not have a defense from hip fractures.
U.S. Pat. No. 4,807,301, which discloses a protective garment for the hip area and uses a size-adjustable, wrap-around form, is adapted to fit under buttocks and includes pockets with shock-absorbent pads of PVC nitrile foam. This garment can change its position on the user's body during sleeping or other daily activities and must be removed e. g. when bathing or going to the toilet if the user needs to defecate. U.S. Pat. No. 5,918,310, which discloses a body protective garment uses a soft, multi-layer polyurethane foam composite for hip protection. This garment must be removed e. g. when bathing or going to the toilet, and, due to the using of flaps, buttons and zippers, this device can not be easily put on, adjusted to fit comfortably and removed by a person who is elderly, infirm or whose fingers, hands and grip have been weakened by arthritis and/or other neuromuscular conditions.
In the USA some companies, for example, “HIProtector” (Wellesley, Mass.; marketed at www.hiprotector.com), “SafeHip” (Tytex, Inc.,Woonsocket, R.I.; www.tytex.com, previously marketed at www.savehip.com, now possibly no longer marketed), HipSaver (Canton, Mass.; marketed at www.hipsaver.com), and J. T. Posey Company (Arcadia, Calif.; marketed at www.posey.com), make or have made different hip protectors.
An analysis of all of these products and the other prior art hip protectors for using under clothing shows that each of these hip protectors (HP) usually has good shock absorbing characteristics, but at the same time has some very serious shortcomings as listed in the following table.
PROBLEMCAUSE of SHORT-CATEGORYSHORTCOMINGCOMINGI. Poor Protection1. HP must be removedConstruction of Hipwhen going to the toilet ifProtection (“HP”)user needs to urinate.2. HP must be removedConstruction of HPwhen going to the toilet ifuser needs to defecate.3. HP must be removedConstruction of HP,when bathing if user needsfabric (cotton orto apply soap and wash thecomparable) is notskin under the HP.intended for repeatedand great stretchingwith following return tothe point of departure.4. Undesired displace-Construction of HP,ment of protective partsfabric (cotton orof the HP relative tocomparable) is intendedthe user's hip.for repeated and greatstretching with follow-ing return to the point ofdeparture; very poorrange of HP sizes.II. Physiological5. After swimming or bath-Fabric (cotton oror Othering the user's skin is incomparable) of HPDiscomfortcontact with moist fabrictypically takes a longof the HP for long periodstime to dry.of time.6. User's sweaty skinFabric (cotton orcomes into contact withcomparable) of HPmoist fabric of HP forabsorbs moisture butextended periods of time.cannot transport moistureaway.7. User's skin under pro-Construction of HPtective pad of HP can not“breathe.”8. Discomfort from hardConstruction of HPshells of HP during sleep-ing or sitting.9. Discomfort from usingConstruction of HPmultiple straps, wraps,buttons and/or zippers.10. HP is too large, heavyConstruction of HP& cumbersome andunaesthetic.
For example, the protector device marketed at www.hipsavers.com includes a specially constructed boxer-style underwear having compressible pads integrally associated with the underwear and positioned so as to ride over the hip joints. The “SlimFit” model of this hip protector has some very serious shortcomings, including from the foregoing list, for example #1, #2, #5, #6 and #7. The hip protector's “HipSaver Nursing Home” model also has the same shortcomings. The hip protector, which is marketed at www.safehip.com and which apparently received a first-place “Silver Award” at the 13th Annual Society on Aging (ASA) Products for Aging Society Design Competition 2001, is made of two, rigid, plastic, concave pieces which are placed in pockets in specially constructed boxer-style underwear such that the plastic pieces ride over and cup the hip joints. This hip protector likewise has some very serious shortcomings from the foregoing list, for example, #1, #2, #5, #6, #7 and #8.
Hip protectors for using under clothing from the prior art, including those on the market noted above, require different models for males and for females. This mean that a company for one model of hip protector with “N” different hip protector sizes has to make and inventory two times (2×N) the number of hip protector versions. Thus, for “K” models ths will require “2×N×K” different versions, causing substantial increases in manufacturing costs & inventory costs. Unfortunately some companies prefers for easier inventory control to make for one model a small number of different hip protector's sizes, for example, only small, medium and large sizes. The result of this can be the incorrect positioning of the protective device on the user's body.
Thus, some patents which may be of general background interest, are:
Patent No.Issue DatePatentee(s)4,089,065May 1978McGee4,641,641February 1987Strock4,737,994April 1988Galton4,807,301February 1989Ferber et al.4,926,883May 1990Strock4,977,623December 1990DeMarco5,062,433November 1991Kummer5,497,511March 1996Zade5,500,952March 1996Keyes5,584,072December 1996Kim et al.5,636,377June 1997Wiener5,722,093March 1998Andresen5,867,842February 1999Pinsley et al.5,918,310July 1999Farahany6,334,443January 2002Olsen
Some additional patents of which the inventor is aware include:
Patent No.Issue DatePatentee(s)4,573,216March 1986Wortberg5,036,548August 1991Grilliot et al5,557,804September 1996Ovortrup et al.5,717,997February 1998Garcia.5,790,981August 1998Bzoch5,836,015November 1998Kristensen et al.6,093,468July 2000Toms et al.6,282,724September 2001Abraham et al.
Also, some publications, copies of which are included with the filing of the present application, along with others, which may be of general background interest, are:
The Use of Quantitative Computer Tomography to Estimate Risk of Fracture of the Hip From Falls, by Jeffrey C. Lots and Wilson C. Hayes, The Journal of Bone and Joint Surgery, vol. 72-A, No. 5, June 1990;
Prediction of Femoral Impact Forces in Falls on the Hip, S. N. Robinovitch, W. C. Hayes, Journal of Biomedical Engineering, vol.113, November 1991; and
Energy Shunting Hip Padding System Femoral Impact Force From a Simulated Fall to Below Fracture Threshold, W. C. Hayes, S. N. Robinovitch, T. A. McMahon, Proc. of Third Injury Prevention Through Biomechanics CDC Symp. 1993;
as well as some internet sites, from which copies of selected pages are included with the filing of the present application, which may be of general background interest include:
                www.hiprotector.com;        www.hipsaver.com                    (apparently no longer active, but see www.tytex.com); and                        www.posey.com.        
The present invention, providing an innovative contribution to the “useful arts,” is designed to ideally provide an innovative, much more effective, comfortable and protective system for protecting, inter alia, the user/patient's hip(s) from damage than achieved in the prior art.